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Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With wAMD, DME and RVO

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ClinicalTrials.gov Identifier: NCT03790852
Recruitment Status : Recruiting
First Posted : January 1, 2019
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Kodiak Sciences Inc

Brief Summary:
This is a Phase 1b open-label study to assess the bioactivity, ocular and systemic safety, tolerability, and pharmacokinetics of repeated injections of KSI-301 at two dose levels: 2.5 mg and 5 mg

Condition or disease Intervention/treatment Phase
Wet Age-related Macular Degeneration Retinal Vein Occlusion Diabetic Macular Edema Drug: KSI-301 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/1b Open Label, Multi-center Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With Wet Age-Related Macular Degeneration (wAMD), Diabetic Macular Edema (DME) and Retinal Vein Occlusion (RVO)
Actual Study Start Date : December 26, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: KSI-301 2.5 mg
KSI-301 2.5 mg, 3 monthly initiating doses, with subsequent doses per protocol-specified retreatment criteria
Drug: KSI-301
Intravitreal injection

Experimental: KSI-301 5 mg
KSI-301 5 mg, 3 monthly initiating doses, with subsequent doses per protocol-specified retreatment criteria
Drug: KSI-301
Intravitreal injection




Primary Outcome Measures :
  1. Incidence of ocular (study eye) and systemic adverse events [ Time Frame: Week 36 ]

Other Outcome Measures:
  1. Mean change in central retinal thickness on optical coherence tomography [ Time Frame: Baseline, Week 36 ]
  2. Mean change in best corrected visual acuity [ Time Frame: Baseline, Week 36 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Wet AMD Cohort

  1. Treatment naïve wet age-related macular degeneration involving the fovea.
  2. A lesion area <30 mm2 (12 disc areas) of any lesion type.
  3. BCVA ETDRS letter score ≤ 78 and ≥ 23 (⁓20/25 to ⁓20/320 Snellen equivalent) in the study eye.
  4. Decrease in vision in the study eye determined by the investigator to be primarily the result of wAMD.

DME Cohort

  1. Treatment naïve diabetic macular edema.
  2. BCVA ETDRS letter score ≤ 78 and ≥ 23 (⁓20/25 to ⁓20/320 Snellen equivalent) in the study eye.
  3. Central subfield thickness (CST) of ≥ 300 microns on SD-OCT (Heidelberg Spectralis or equivalent).
  4. Decrease in vision in the study eye determined by the investigator to be primarily the result of DME.

RVO Cohort

  1. Treatment naïve retinal vein occlusion with macular edema and secondary visual impairment.
  2. BCVA ETDRS letter score ≤ 78 and ≥ 23 (⁓20/25 to ⁓20/320 Snellen equivalent) in the study eye.
  3. Central subfield thickness (CST) of ≥ 300 microns on SD-OCT (Heidelberg Spectralis or equivalent).
  4. Branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO) are both eligible.
  5. Decrease in vision in the study eye determined by the investigator to be primarily the result of macular edema secondary to RVO.

General Inclusion Criteria

  • Adults ≥ 21 years.

Exclusion Criteria:

Wet AMD Cohort:

  1. Choroidal neovascularization due to causes other than age-related macular degeneration in the study eye.
  2. Geographic atrophy and/or subretinal fibrosis involving the fovea of the study eye.
  3. Prior intravitreal anti-VEGF therapy in the study eye.

DME Cohort:

  1. Initial diagnosis of DME of more than 6 months from screening in the study eye.
  2. Hard exudates in the fovea.
  3. Prior intravitreal anti-VEGF therapy or steroid injection, or steroid implant (dexamethasone or triamcinolone) in the study eye.
  4. Moderate or dense vitreous hemorrhage preventing clear. visualization of the macula or optic disc in the study eye.
  5. Fibrovascular proliferation or tractional retinal detachment in the posterior pole in the study eye. If traction is present outside the posterior pole, it should be considered not at risk of increasing and threatening the macula with the use of anti-VEGF injections, in the investigator's judgement.

RVO Cohort:

  1. Initial diagnosis of RVO of more than 4 months from screening in the study eye.
  2. Active retinal or iris neovascularization in the study eye.
  3. Prior intravitreal anti-VEGF therapy or steroid injection, or steroid implant (dexamethasone or triamcinolone) in the study eye.

For all phase 1b subjects:

  1. Uncontrolled glaucoma (defined as intraocular pressure ≥ 25 mmHg despite treatment with antiglaucoma medication) in the study eye.
  2. History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
  3. Any history of uveitis in either eye.
  4. Significant media opacities, including visually significant cataract, in the study eye that might interfere with visual acuity assessments, optical coherence tomography, fundus photography, or with examination of the eye for assessment of safety.
  5. Prior vitrectomy surgery in the study eye.
  6. Active retinal disease other than the conditions under investigation.
  7. Active ocular or periocular infection or inflammation in either eye.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03790852


Contacts
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Contact: Jason Ehrlich, MD, PhD 6502810836 jehrlich@kodiak.com
Contact: Pablo Velazquez-Martin, MD 6502810844 pablovm@kodiak.com

Locations
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United States, Arizona
Kodiak Sciences Investigative Site Recruiting
Phoenix, Arizona, United States, 85053
United States, California
Kodiak Sciences Investigative Site Recruiting
Beverly Hills, California, United States, 90211
Kodiak Sciences Investigative Site Recruiting
Mountain View, California, United States, 94040
Kodiak Sciences Investigative Site Recruiting
Palo Alto, California, United States, 94303
Kodiak Sciences Investigative Site Active, not recruiting
San Francisco, California, United States, 94109
United States, Florida
Kodiak Sciences Investigative Site Recruiting
Saint Petersburg, Florida, United States, 33711
United States, Nevada
Kodiak Sciences Investigative Site Recruiting
Reno, Nevada, United States, 89502
United States, Pennsylvania
Kodiak Sciences Investigative Site Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Kodiak Sciences Investigative Site Not yet recruiting
Florence, South Carolina, United States, 29501
United States, Texas
Kodiak Sciences Investigative Site Recruiting
Abilene, Texas, United States, 79606
Kodiak Sciences Investigative Site Recruiting
Austin, Texas, United States, 78705
Kodiak Sciences Investigative Site Recruiting
Houston, Texas, United States, 77030
Kodiak Sciences Investigative Site Recruiting
The Woodlands, Texas, United States, 77384
Sponsors and Collaborators
Kodiak Sciences Inc

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Responsible Party: Kodiak Sciences Inc
ClinicalTrials.gov Identifier: NCT03790852     History of Changes
Other Study ID Numbers: KSI-CL-101
First Posted: January 1, 2019    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kodiak Sciences Inc:
DME
wAMD
RVO
KSI-301
Kodiak

Additional relevant MeSH terms:
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Macular Degeneration
Macular Edema
Retinal Vein Occlusion
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases